FDA.reportPublic FDA data

Celecoxib

Product NDC
50436-3982
11-digit product format
504363982
Labeler code
50436
Product ID
50436-3982_aab4e662-7458-41e6-b420-276d64c164a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076898
Marketing category
ANDA
Marketing start
2014-12-10
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-3982-12024-01-30C16284748780-11030e365-2e19-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3982-1Celecoxib30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3982-1EA - Each50436-3982a3669304-fb8d-4c44-81b7-00b424fd017612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3982CELECOXIB CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20221018_7684a771-9589-4753-bf3a-4f997205af6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN7684a771-9589-4753-bf3a-4f997205af6b2
205322celecoxib 100 MG Oral CapsuleSCD7684a771-9589-4753-bf3a-4f997205af6b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-3982-15043639820130 CAPSULE in 1 BOTTLE (50436-3982-1) 30 capsule2022-10-010000-00-00NoNoCurrent